MAUDE Adverse Event Report: PRESTIGE BRANDS, INC. THE DOCTOR'S NIGHTGUARD; MOUTHGUARD, OVER-THE-COUNTER

Lot Number 15714

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reaction (2414)

Event Date 10/29/2014

Event Type  Injury  

Event Description

A (b)(6) year-old female consumer reported experiencing wheezing, coughing, and asthma-like reaction while using the doctor's nightguard advance comfort (mouthguard, over-the-counter).The consumer reportedly started using the doctor's nightguard advance comfort for protection against bruxism on (b)(6) 2014.After approximately five minutes of use, the patient experienced/developed wheezing, coughing, and asthma-like reaction.At the time of this report, the resolution of the patient's symptoms is unknown.The consumer reported treating her symptoms by taking benadryl, using her inhaler (unspecified) and rinsing her mouth.The consumer is currently taking lasix, heart medication (unk) and has a medical history of heart issues, diabetes, and asthma.No further information is available.

• Brand Name: THE DOCTOR'S NIGHTGUARD
• Type of Device: MOUTHGUARD, OVER-THE-COUNTER
• Manufacturer (Section D): PRESTIGE BRANDS, INC.; tarrytown NC 10591
• Manufacturer Contact: 660 white plains road; tarrytown, NY 10591 ; 9145248700
• MDR Report Key: 4337020
• MDR Text Key: 5140375
• Report Number: 2529596-2014-00005
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 15714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED HEART MEDICATION; LASIX
• Patient Outcome(s): Other
• Patient Age: 58 YR